Chronic Non-inflammatory Pains in Rheumatopediatrics

NCT03740347 | Withdrawn

• 2 other identifiers: APHP1802302018-A02317-48
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity. Secondary objectives are, first to determine intensity of pain and its repercussion in daily life and second to determine risk factor of chronic pain.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile idiopathic arthritis; chronic pain; anxiety; depression; sleepiness; quality of life

Outcome Measures

Primary Outcomes (1)

• Frequency of chronic pain and its relationship with disease activity

  Chronic pain will be defined by the presence of recurrent or permanent moderate pain (Visual Analogue Scale (VAS) \> 3 / 10), present more than 3 days a week. Disease activity will be evaluated by the clinical Juvenile Arthritis Disease Activity Score (JADAS) and the definition of three groups: inactive disease, minimal disease activity and active disease.

  Day 0

Secondary Outcomes (5)

• Chronic pain and disease repercussions

  Day 0

• Repercussions of pain on patient anxiety

  Day 0

• Repercussions of pain on depression symptoms

  Day 0

• Repercussions of pain on quality of life

  Day 0

• Repercussions of pain on patient daytime sleepiness

  Day 0

Study Arms (1)

Juvenile idiopathic arthritis and chronic pain

Patients followed for juvenile idiopathic arthritis and chronic pain in Necker Hospital

Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

Response to questionnaires evaluating chronic pain and its repercussion : * anxiety questionnaire (Revised Children's Manifest Anxiety Scale), * depression questionnaire (Children's Depression Inventory score), * sleepiness questionnaire (Pediatric Daytime Sleepiness Scale), * quality of life questionnaire (Pediatric Quality of Life inventory score).

Also known as: Evaluation of the chronic pain repercussion in juvenile idiopathic arthritis

Juvenile idiopathic arthritis and chronic pain

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 12 years of age followed for juvenile idiopathic arthritis in the reference center at Necker-Enfants malades Hospital (RAISE)

You may qualify if:

• Child from 12 to 17 years old
• Follow-up to Necker Hospital by a rheumatologist at the reference center for juvenile idiopathic arthritis (RAISE), regardless of the form
• Not opposed to participating in the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital

Paris, 75015, France

Location

Related Publications (10)

• Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007 Mar 3;369(9563):767-778. doi: 10.1016/S0140-6736(07)60363-8.

  PMID: 17336654 BACKGROUND

• Consolaro A, Ravelli A. Paediatric rheumatology: Juvenile idiopathic arthritis--are biologic agents effective for pain? Nat Rev Rheumatol. 2013 Aug;9(8):447-8. doi: 10.1038/nrrheum.2013.108. Epub 2013 Jul 2.

  PMID: 23820859 BACKGROUND

• Tupper SM, Rosenberg AM, Pahwa P, Stinson JN. Pain intensity variability and its relationship with quality of life in youths with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):563-70. doi: 10.1002/acr.21850.

  PMID: 22972759 BACKGROUND

• Lalloo C, Stinson JN. Assessment and treatment of pain in children and adolescents. Best Pract Res Clin Rheumatol. 2014 Apr;28(2):315-30. doi: 10.1016/j.berh.2014.05.003.

  PMID: 24974065 BACKGROUND

• Duffield SJ, Miller N, Zhao S, Goodson NJ. Concomitant fibromyalgia complicating chronic inflammatory arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2018 Aug 1;57(8):1453-1460. doi: 10.1093/rheumatology/key112.

  PMID: 29788461 BACKGROUND

• McErlane F, Beresford MW, Baildam EM, Chieng SE, Davidson JE, Foster HE, Gardner-Medwin J, Lunt M, Wedderburn LR, Thomson W, Hyrich KL; Childhood Arthritis Prospective Study (CAPS). Validity of a three-variable Juvenile Arthritis Disease Activity Score in children with new-onset juvenile idiopathic arthritis. Ann Rheum Dis. 2013 Dec;72(12):1983-8. doi: 10.1136/annrheumdis-2012-202031. Epub 2012 Dec 20.

  PMID: 23256951 BACKGROUND

• Reynolds CR. Concurrent validity of "What I think and feel:" the Revised Children's Manifest Anxiety Scale. J Consult Clin Psychol. 1980 Dec;48(6):774-5. doi: 10.1037//0022-006x.48.6.774. No abstract available.

  PMID: 7440835 BACKGROUND

• Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.

  PMID: 4089116 BACKGROUND

• Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.

  PMID: 10024117 BACKGROUND

• Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.

  PMID: 12841372 BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile; Chronic Pain; Anxiety Disorders; Depression; Sleepiness

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maxime Goirand, MD, PhD

  AP-HP, Functional Unit of "Pain and Palliative Medicine" - Necker-Enfants malades Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 14, 2018
• Study Start: November 6, 2018
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: September 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)